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This Study is a Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15275 in Healthy and Obese Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM15275 | Experimental | Active comparator: Part A: single-ascending dose Single doses of HM15275 in healthy adults administered via subcutaneous injection. Part B: multiple-ascending dose Multiple doses of HM15275 in obese adults administered via subcutaneous injection. |
|
| Placebo of HM15275 | Placebo Comparator | Placebo comparator: Part A: single-ascending dose Single doses of HM15275 placebo in healthy adults administered via subcutaneous injection. Part B: multiple-ascending dose Multiple doses of HM15275 placebo in obese adults administered via subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM15275 | Drug | HM15275 is a sterile solution for subcutaneous injection, supplied pre-filled syringes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Safety and Tolerability | Number of participants with treatment-emergent adverse events (TEAEs) after a single subcutaneous dose | Up to Day 29 |
| Part B: Safety and Tolerability | Number of participants with treatment-emergent adverse events (TEAEs) after multiple subcutaneous doses | Up to Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics | Plasma concentration profile of HM15275 over time after a single subcutaneous dose | Up to Day 29 |
| Part B: Pharmacokinetics | Plasma concentration profile of HM15275 over time after multiple subcutaneous doses |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacodynamics | Change in body weight (kg) from baseline | Up to Day 29 |
| Part B: Pharmacodynamics | Change in body weight (kg) from baseline |
Inclusion Criteria:
Female and male adults, ages ≥ 18 and ≤ 65 years.
Part A: Healthy subjects with body mass index (BMI) ≥ 20.0 kg/m2 and ≤ 27 kg/m2.
Part B: Obese subjects with BMI ≥ 30.0 kg/m2 and ≤ 45.0 kg/m2 with a stable body weight for 3 months prior to screening (defined as change < 5%).
HbA1c < 6.5 % [based on American Diabetes Association, 2023].
Female subjects must be non-pregnant and non-lactating.
Subjects must be able to provide written informed consent and are willing to follow study procedures and commitment to the study duration.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProSciento, Inc. | Chula Vista | California | 91911 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Part A: single-ascending dose Part B: multiple-ascending dose
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| Placebo of HM15275 | Drug | A sterile, matching solution supplied in pre-filled syringes. |
|
| Up to Day 57 |
| Up to Day 57 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |